IQS Team
IQS consultants are focused on tackling challenging problems involving pharmaceutical development and commercialization. Each consultant brings a wealth of expertise along with the tactfulness required to work towards an optimal solution which minimizes compliance and business risk in a cost-effective manner.
Jim Morris
Founder and Principal Consultant
BA Biological Sciences, MBA/MA Industrial Organization
Brief bio:
Jim has been involved in plant operations over 35 years, starting as a shift supervisor with Avon Products; and subsequently, at Pfizer Inc with roles in production, quality assurance and regulatory CMC over a 16-year timeframe. At Pfizer, Jim was involved in several large-scale product launches, aseptic operations, combination product support, product transfers and quality system improvement initiatives. Subsequent work at Cilag AG and Mass Biologics included a plant start up for biologics manufacture, CDMO oversight, and Quality / Regulatory operations oversight. Jim initiated his consulting career full time with NSF Health Sciences in 2009 servicing clients in the US and internationally in the areas of investigations system improvement, quality systems improvement, GMP assessment and audit, excipient GMP certification, technical product investigation and CMC support.
Don DeRoo
IQS Consultant
BS, Biochemistry BS, Chemical Engineering
Brief bio: Don has more than 40 years of experience in biopharma and small molecules, with a focus on quality, regulatory affairs (CMC), and manufacturing. Key roles included 13 years with Wyeth-Lederle’s vaccine group where he was responsible for the manufacture of viral vaccines for clinical trials and the validation/commissioning of a new multi-use manufacturing facility. Subsequent roles at W-L included leadership of the Marietta PA Regulatory Affairs group and responsibility for management of Consent Decree activities for the site. At Purdue Pharma, he formed the corporate quality GXP compliance group which drove a 90% reduction in FDA inspection observations over a 3-year period. At Accentia Biopharmaceuticals and the Ludwig Institute for Cancer Research Don was responsible for Quality Assurance, Regulatory Affairs and clinical supply manufacturing by CDMOs. At NAMSA and Lonza, he led site and corporate QA/QC groups, designing and implementing programs for quality system and compliance improvements, customer and regulatory agency interactions, and design / licensure of new manufacturing facilities.
Frank Koppenhagen
IQS CMC Consultant
PhD in Pharmacy | MSc in Biology
Brief bio: Frank Koppenhagen is a seasoned technical leader with over 25 years of experience in the pharmaceutical and biotechnology sectors. His expertise spans complex Chemistry, Manufacturing, and Controls (CMC) programs, strategic drug development, and operational excellence. Frank brings significant technical skills in pharmaceutical development, particularly in combination products, including orally inhaled and nasal drug products (OINDP), development strategy, formulation science, and regulatory affairs. He has overseen enhanced or performance-based drug development approaches from early-stage R&D through to commercialization. At Spirovant Sciences, Frank served as Vice President of Pulmonary Delivery, where he was instrumental in advancing the pulmonary delivery of viral vector gene therapies. Frank’s leadership at Teva and Lupin involved establishing and managing R&D and manufacturing sites, recruiting and building R&D teams, and ensuring seamless global operational integration. At Glenmark, Frank played a pivotal role in late-stage development, including the successful development of Ryaltris, a major nasal spray for allergic rhinitis. As a CMC Consultant, Frank remains attuned to the needs of startup companies, providing the CMC road map, and de-risking development projects.
John T. LaMagna
IQS Consultant
BE Chemical Engineering, ME Chemical Engineering, MBA Finance
Brief bio: Over a 35-year career with Pfizer, John was involved in large-scale product launches and managed an aseptic manufacturing and filling facility for dosage form products. Subsequent assignments included leading operations for a bulk aseptic recrystallization facility and site engineering including project management, maintenance, energy management, and utilities. John then moved into a role in Manufacturing Strategy, which coordinated manufacturing network studies and had oversight for multiple product transfers across the Pfizer network with the goal of optimizing product supply. Subsequently, John was responsible for leading a quality improvement program at a Pfizer site—the scope included manufacturing optimization, deviation reduction, and root cause analysis.
Peter Tomlinson
IQS Consultant
PhD Analytical Chemistry, MBA General Management and QP
Brief bio: Peter’s experience includes quality assurance, operations and general management in pharmaceutical manufacturing operations. At Taro Pharmaceuticals, Peter was involved in implementing programs to ensure a Canadian based cream and ointment manufacturing met FDA requirements and led the organization through its first FDA preapproval and general compliance inspections. At Supratek Pharma, Peter was responsible for the preclinical and clinical development of a novel drug delivery technology improving the delivery of existing cancer therapeutics. Peter established his own consulting company in 2000 based in Toronto focused on running CMC programs for small biotechnology and pharmaceutical companies taking new products into clinical trials. Peter has been a QP under EU regulations since 1987 and is also involved in managing the importation of clinical supplies into the EU for products manufactured in North Ameria.